Cleared Traditional

K896097 - VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY

K896097 is an FDA 510(k) clearance for VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV)..., manufactured by Vitek Systems, Inc.. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K896097 · Vitek Systems, Inc. · Microbiology device
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Feb 1990
Decision
129d
Days
Class 1
Risk

K896097 is an FDA 510(k) clearance for the VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitek Systems, Inc. devices

FDA 510(k) Submission Details - K896097

510(k) Number K896097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1989
Decision Date February 26, 1990
Days to Decision 129 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 102d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

GQG Device Classification - Class 1, General Controls

Product Code GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

All 27
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K896097.
BD DIRECTIGEN EZ RSV KIT
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BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
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RSV ANTIGEN CONTROL SLIDES
K964870 · Viral Antigens, Inc. · Mar 1997
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · Whittaker Bioproducts, Inc. · Jan 1989
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · Abbott Laboratories · Jun 1988